BIT Group has launched a product line of customizable IVD white label instruments. During recent years, BIT has invested capital and resources developing customizable, ready-to-use IVD systems to address a growing demand.
“The IVD market is challenging for our clients,” said Marius Balger, CEO at BIT. “OEM’s must adhere to a growing number of evolving IVD regulatory requirements, while remaining innovative and competitive. Additionally, there is constant pressure to keep costs down and excel in the operation of their own businesses.”
After 40 years developing and manufacturing precision IVD instruments for global markets, BIT has achieved expertise, as well as a comprehensive understanding of global regulatory affairs, a vast knowledge base of new instrument innovations and software advances, and industrial design for manufacturability.
“OEM’s must adhere to a growing number of evolving IVD regulatory requirements, while remaining innovative and competitive,” Balger said. “Additionally, there is constant pressure to keep costs down and excel in the operation of their own businesses.”
BIT focused its resources on developing a full range of white label, ready-to use IVD solutions where there was the most demand on instruments performing standard applications within market segments such as Hematology, Clinical Chemistry and Homeostasis Diagnostics. BIT’s white label IVD instruments are entirely customizable with regard to functionality, consumables and reagents. Even the industrial design of the instrument can be customized so the new white label instrument can emulate an OEM’s existing product line.
For the OEM, BIT’s white label solutions translate into a lower investment in resources, increased speed to market and enhanced cost efficiency.
“And most important,” said Balger. “OEM’s can focus on their own core competencies while BIT provides them with proven, innovative, fully-supported, highly-reliable, IVD instruments.”
BIT provides contract product development, manufacturing and after-sales services for life science, medical and IVD instrumentation OEMs. Quality standards include GMP, FDA registered, ISO13485 & 9001, QSR, Class I, II and III. BIT’s global operations in located in USA, Germany, France, China and Japan deliver precision engineered, cost effective systems solutions. Pre-engineered BIT SMARTSOLUTIONS platform technologies reduce development cost and time-to-market; lean manufacturing centers and global supply chain enable competitive product cost.